A Study to Demonstrate Immunogenicity, Tolerability, and Manufacturing Consistency of a Multivalent Human Papillomavirus (HPV) L1 Virus-Like Particle (VLP) Vaccine Administered in Preadolescents and Adolescents (9 to 15 year olds), with a Comparison to Young Women (16 to 26 year olds)

MSD Finland Oy0 个研究点目标入组 2,800 人开始时间: 2009年7月13日最近更新: 2014年5月19日

适应症

试验速览

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•1.Subject is male or female, between the ages of 9 years and 0 days and 15 years and 364 days on the day of enrolment, or the subject is female between the ages of 16 years and 0 days and 26 years and 364 days on the day of enrollment.
•2.Subjects age 9-15 must not yet have had coitarche and does not plan on becoming sexually active during the Day 1 through Month 7 period.
•3.Subjects age 16-26 have a lifetime history of 0 to 4 male and/or female sexual partners at the time of enrollment.
•4.Subject has never had Pap testing or has only had normal Pap test results.
•5.Subject (or, for minor subjects, parent/legal guardian and subject) fully understands study procedures, alternative treatments available, the risks involved with the study, and voluntarily agrees to participate by giving written informed consent.
•Are the trial subjects under 18? yes
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•1.Subject is pregnant (as determined by a serum pregnancy test or urine pregnancy test that is sensitive to 25 mIU/mL ß-hCG).
•2.Subject has received a marketed HPV vaccine, or has participated in an HPV vaccine clinical trial and has received either active agent or placebo.
•3.Subject is concurrently enrolled in clinical studies of investigational agents or studies involving collection of cervical specimens.
•4.Subject has a known allergy to any vaccine component, including aluminum, yeast, or BENZONASE™ (nuclease, Nycomed [used to remove residual nucleic acids from this and other vaccines]).
•5.Subject is currently immunocompromised or has been diagnosed as having a congenital or acquired immunodeficiency, HIV infection, lymphoma, leukemia, systemic lupus erythematosus (SLE), rheumatoid arthritis, juvenile rheumatoid arthritis (JRA), inflammatory bowel disease, or other autoimmune condition.
•6.Subject has a history of an abnormal cervical biopsy result (showing cervical intraepithelial neoplasia [CIN] or worse).
•7.Subject has a history of or clinical evidence at the Day 1 pelvic examination of HPV-related external genital lesions (e.g., condyloma acuminata or vulvar intraepithelial neoplasia [VIN]) or external genital cancer, HPV-related vaginal lesions (e.g., condyloma acuminata or vaginal intraepithelial neoplasia [VaIN]) or vaginal cancer.

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